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Apatinib Combined With EGFR-TKI for Advanced Slow-progressed EGFR-TKI Resistant NSCLC (AFLC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03428022
Recruitment Status : Unknown
Verified April 2019 by Cao，Hua, Shenzhen People's Hospital.
Recruitment status was:  Recruiting
First Posted : February 9, 2018
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Cao，Hua, Shenzhen People's Hospital

Study Description
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Brief Summary:
Patients with advanced non-small cell lung cancer (NSCLC) who progress slowly after Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors（EGFR-TKI）resistance will be treated with Apatinib and EGFR-TKI. The primary objective is the disease progression free survival of the patients.

Condition or disease Intervention/treatment Phase
NSCLC Apatinib EGFR-TKI Drug: Apatinib（Tab. 500mg/d） combined with EGFR-TKI（as previously） Phase 3

Detailed Description:
Patients with advanced non-small cell lung cancer (NSCLC) who had treated with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors（EGFR-TKI） and progressed slowly because of resistance are underwent with apatinib mesylate and continuous EGFR-TKI. The primary objective is the disease progression free survival of the patients. The secondary goals are overall survival, duration of response, objective response rates, disease control rates, quality of life scores and drug safety. Currently such patients are treated with EGFR-TKI continuously, but 3 months later, the disease will be progressed rapidly. This study will bring a new treatment that are more effective, less toxic and more convenient for NSCLC-patients with EGFR-TKI resistance.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Apatinib Combined With Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors Used for the Advanced Slow-progressed Non Small Cell Lung Cancer Patients With EGFR-TKI Resistance
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Apatinib combined with EGFR-TKI
Apatinib（Tablet（Tab. ）500millgram（mg）/day（d）） combined with EGFR-TKI（as previously）
 Drug: Apatinib（Tab. 500mg/d） combined with EGFR-TKI（as previously）
Patients with advanced non-small cell lung cancer (NSCLC) who had treated with EGFR-TKI and progressed slowly because of resistance are underwent with apatinib mesylate and continuous EGFR-TKI.


Outcome Measures
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Primary Outcome Measures :
  1. PFS [ Time Frame: 3 months ]
    the disease progression free survival of patients


Secondary Outcome Measures :
  1. OS [ Time Frame: 8 months ]
    overall survival

  2. ORR [ Time Frame: 6 months ]
    objective response rates


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically confirmed advanced (stage IV) non-squamous, non-small cell lung cancer with measurable lesions
  • Electronics Coordinating Grop（ECOG）score：0-2
  • Expected survival over 3months
  • Hemoglobin(HB)≥90 gram(g)/liter(L)；absolute neutrophil count(ANC)≥1.5×109/L；platelet(PLT)≥80×109/L；total-bilirubin（T-BIL）<1.5 upper limit of normal value（ULN）；alanine aminotransferase（ALT）and aspartate aminotransferase（AST）<2.5 ULN；Cr≤1.25ULN

Exclusion Criteria:

  • Brain metastases, meningococcal meningitis, patients with spinal cord compression with evidence of imaging (computed tomography（CT） / magnetic resonance imaging （MRI）, et cetera（etc.）);
  • Uncontrolled hypertension (systolic blood pressure（BP）≥140 millimeter mercury column（mmHg） or diastolic BP ≥90 mmHg, despite optimal drug therapy);
  • Hemorrhoid dysfunction (inernational standard ratio(INR)> 1.5 or prothrombin time (PT)> ULN + 4 seconds or activated partial thromboplastin(APTT)> 1.5 ULN) with bleeding tendency or undergoing thrombolytic or anticoagulant therapy;
  • Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or the like;
  • Patients underwent major surgery or severe traumatic injury, fracture or ulcer in 4 weeks before study;
  • Urine routine urine protein ≥ +++, or confirmed 24 hours urinary protein content ≥ 1.0 g;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03428022


Contacts
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Contact: CAO HUA, MD 0086-755-22942406 caohua1206@hotmail.com

Locations
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China, Guangdong
Shenzhen People's Hospital Recruiting
Shenzhen, Guangdong, China, 518020
Contact: CAO HUA, MD    0086-755-22942406    caohua1206@hotmail.com   
Sponsors and Collaborators
Shenzhen People's Hospital
Investigators
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Principal Investigator: CAO HUA, MD Shenzhen People's Hospital
More Information
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Responsible Party: Cao，Hua, associate chief physician, Shenzhen People's Hospital
ClinicalTrials.gov Identifier: NCT03428022    
Other Study ID Numbers: AFLC
First Posted: February 9, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cao，Hua, Shenzhen People's Hospital:
Apatinib
EGFR-TKI resistance
slowly progress
Additional relevant MeSH terms:
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Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action